An exciting new opportunity has opened for a Technical Writer with a Limerick based medical device multinational on an initial 12 month contract basis. The successful candidate will provide support for the technical/validation documentation and support activities within engineering to ensure that all activities associated with change control and general engineering support tasks are completed in a fully compliant manner. The role requires collaboration with the Quality Engineering team to ensure Validation/Quality Policies and Procedures are maintained.
Role of this position
- Perform technical writing, research, and related editing functions to prepare documents, test plans, user cases, project manuals, business proposals, reports, briefings, presentations, guidelines, and other written materials.
- Perform technical writing activities and assist the project engineers in the generation of all validation documentations including URS's, FAT's, SAT's, test plans, deviations and discrepancies.
- Update and edit Operations Procedures and Work Instructions, project manuals, project presentations and reports.
- Assist with attachment and upload of deliverables associated with change control.
- Help with non-critical Validation execution under direction of Engineering.
- Assist with purchasing and spare parts ordering.
- Support Engineering with planning and department development.
- Ensure all quality/validation documents are authorized and appropriate compliance approval is gained.
- Qualification in an appropriate discipline (e.g. Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base. Bachelors degree preferred.
- Knowledge of european regulations associated with the medical device industry desirable.
- Technical Writing experience highly desirable.
- Understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations desirable.
- Experience working in a regulated environment would be an advantage.
Please contact Michelle Galvin on (091 373 938) email@example.com for further information on this role.
CareerWise Recruitment (In Search of Excellence)